CONTEXT: Digital scanning systems are becoming more and more popular with the advent of the
      COVID-19 pandemic. The risks surrounding aerosol-generating procedures (AGP) has resulted in
      practitioners changing their normal practice and finding alternative methods to continue
      managing their patients. Digital (intraoral) scanners are often used to show patients
      treatment options and help in educating them regarding their oral hygiene as it produces an
      almost instant digital image of their teeth. Conventional methods using alginate impressions
      produce study models which are created in dental plaster or stone, involving a lab cost and a
      greater environmental impact but remain a popular method of recording a patient's teeth and
      bite.

      OBJECTIVE: To investigate patient experience, operator experience and preference in intraoral
      scanning versus alginate impression taking in the orthodontic setting.

      DESIGN, SETTING AND SUBJECTS: A randomised controlled two-period crossover trial to be
      conducted in a UK secondary care setting involving 84 participants ready to start orthodontic
      treatment, with no experience of impressions/intraoral scans in the last 2 years. Patients
      with cleft lip and/or palate or recent research involvement will be excluded.

      OUTCOMES: A modified visual analogue scale, will be used to measure patient and operator
      reported outcomes (e.g. patient comfort, operator confidence, perceived time taken and
      induction of cough/gag reflex) following an alginate impression or an intraoral scan using
      Trios® 3 intraoral scanner (3Shape). The time taken for each procedure will also be measured.
      Lastly, operator preference will be recorded.

      CONCLUSION: The proposed study aims to add to the limited evidence base, providing
      information regarding the use of intraoral scanners compared to alginate impressions from
      both the orthodontic patient and operator perspectives.

Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions

Orthodontic Patient Experience

Eligible patients are to be identified during a virtual dental health education (DHE)
      appointment prior to their orthodontic treatment commencing. With consent, the trial will be
      discussed with patients meeting the inclusion criteria and they will be provided with
      relevant trial information in both leaflet and video format. The potential participant and/or
      their parent or guardian will be allowed time (3 weeks) to consider the information and ask
      any relevant questions. If they choose to take part in the trial, they will be recruited and
      allocated randomly into mixed block sizes using an online randomisation tool. If they choose
      not to participate, normal orthodontic care will continue. For children, unable to consent
      for themselves, assent will also be sought.

      Once the participant has provided appropriate consent/assent, the following procedure will be
      followed:

      • One unit will be set up with an operator and a nurse

      Participants in the alginate impression group:

        1. The unit the participant will be treated in, will be set up appropriately with relevant
           materials ready.

             -  The alginate to be used will be: Zhermack orthoprint® orthodontic alginate material

        2. A timer will be started when the participant is seated in the chair

        3. The operator will carry out the impression as normal:

             -  Tray selection

             -  Alginate mixing

             -  Tray seating

             -  Alginate setting

             -  Tray removal

             -  Wax bite

             -  Clean up of the participant's face

        4. The timer will be stopped

        5. Questionnaires

             -  Participant will be asked to complete a questionnaire (modified VAS using pictorial
                anchors)

             -  Operator will be asked to complete a questionnaire

        6. These will be collected for analysis

        7. The participant will then have records taken as part of their normal orthodontic care,
           if not done already +/- a discussion to consent patient for orthodontic treatment

        8. The participants will return a minimum 4 weeks later for a second appointment (if they
           have not had an intraoral scan already) in which they will undertake the process for
           'Participants in the intraoral scanner group'

      Participants in the intraoral scanner group:

        1. The unit the participant will be treated in, will be set up appropriately with relevant
           materials ready. The interchangeable covering will be placed over the scanner ready for
           use.

             -  The intraoral scanning device to be used will be: Trios® 3 intraoral scanner
                (3Shape)

             -  The staff will be appropriately trained and will be requested to carry out a
                minimum of 10 scans prior to the study beginning

        2. A timer will be started when the participant is seated in the chair

        3. The scan will be carried out as per the manufacturer's directions to include a full
           mouth scan and bite registration and saved on the scanner system.

        4. The timer will be stopped

        5. Questionnaires

             -  Participant will be asked to complete a questionnaire (modified VAS using pictorial
                anchors)

             -  Operator will be asked to complete a questionnaire

        6. These will be collected for analysis

        7. The participant will then have records taken as part of their normal orthodontic care,
           if not done already +/- a discussion to consent patient for orthodontic treatment +/-
           fit of any orthodontic appliance required.

        8. The participants will return a minimum 4 weeks later for a second appointment (if they
           have not had an alginate impression already) in which they will undertake the process
           for 'Participants in the alginate impression group'

      A minimum of 4 weeks between the two appointments allows for an adequate washout period and
      it also fits with orthodontic laboratory work timelines within the hospital.

      Once all participant data is obtained, the operators will be asked a single question to
      indicate their preference towards a single method.

      Any participant and/or their parent or guardian, if appropriate who wishes to withdraw at any
      point during the trial can do so without reason and without this affecting or prejudicing the
      delivery of their orthodontic care.

      Analyses:

        -  Primary outcome - the difference between the paired visual analogue scale (VAS) scores
           will be compared using analysis of variance (ANOVA) that will analyse the period,
           treatment and sequence effects of the comfort scores.

        -  Secondary outcomes - the 8 secondary outcomes measured by VAS and the time taken to make
           the impression or complete the scan will be compared using analyses of variance suitable
           for a crossover study, that will test the period, treatment and sequence effects on
           these nine secondary outcomes. The operator's preference will be reported using
           descriptive statistics. The frequency and percentages will be recorded.

      Only the primary analysis will be compared against a specific level of significance. The
      secondary analyses should be considered as hypothesis generating rather than providing firm
      conclusions.

Intraoral scan

Alginate impressions

Orthodontic Patient Experience of Intraoral Scanners Versus Alginate Impressions in the UK: a Single-Centre Randomised Controlled Crossover Trial

A 100mm modified Visual Analogue Scale (VA scale) measuring patient comfort during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A 100mm modified Visual Analogue Scale (VA scale) measuring pain during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A 100mm modified Visual Analogue Scale (VA scale) measuring relative speed during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A 100mm modified Visual Analogue Scale (VA scale) measuring nausea and/or coughing during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A 100mm modified Visual Analogue Scale (VA scale) measuring likely recommendation and/or coughing during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A 100mm Visual Analogue Scale (VA scale) measuring ease of impression for the operator during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A 100mm Visual Analogue Scale (VA scale) measuring operator confidence during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A 100mm Visual Analogue Scale (VA scale) measuring relative speed of impression for the operator during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A 100mm Visual Analogue Scale (VA scale) measuring operator experience of sickness or coughing during intraoral scanning taking versus alginate impressions taken in the orthodontic setting. A higher score would indicate a more negative experience.

A quantitative time measure will be recorded for each impression method

A simple question to determine operator preference for intraoral scanning versus alginate impressions.

The participant will have alginate impressions taken for orthodontic treatment records first. Followed by a digital intraoral scan a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.

The participant will have a digital intraoral taken for orthodontic treatment records first. Followed by alginate impressions a minimum of 4-6 weeks washout period. After each intervention, the participant will complete a modified visual analogue scale (VAS) questionnaire about their experience.

Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status